Evaluate tofacitinib efficacy, safety and persistence by sex in rheumatoid arthritis (RA).

Post hoc analyses using data from phase III placebo-controlled randomised controlled trials (ORAL Scan, ORAL Sync and ORAL Standard).

ORAL Scan, ORAL Sync and ORAL Standard were global, multicentre trials conducted across 111, 114 and 115 sites, respectively.

The trials enrolled adults with active RA and prior inadequate response to methotrexate (ORAL Scan/ORAL Standard) or ≥1 conventional synthetic or biologic disease-modifying antirheumatic drug (ORAL Sync). Post hoc analyses included 2265 patients (1870 female and 395 male).

Patients received tofacitinib 5 mg or 10 mg two times a day, adalimumab or placebo.

Efficacy outcomes to month 12 included American College of Rheumatology (ACR)20, 50 and 70 responses, Disease Activity Score in 28 joints (DAS28) (erythrocyte sedimentation rate (ESR))-defined low disease activity (LDA) and remission, DAS28 (C reactive protein (CRP)) ≤3.2 and

At baseline, female patients had similar DAS28(CRP and ESR), slightly higher HAQ-DI and lower FACIT-F scores versus male patients (n=395). ORs for active treatments (tofacitinib and adalimumab) versus placebo were generally >1 for ACR20, 50 and 70 responses, DAS28(CRP) ≤3.2 and

In post hoc analyses, tofacitinib was efficacious across both sexes, with higher responses in males observed particularly for more stringent composite endpoints and patient-reported outcomes. Findings are generally consistent with studies of other advanced RA therapies. Safety and persistence were similar across sexes. Interpretation is limited by the small proportion of male patients (

NCT00847613, NCT00856544, NCT00853385, NCT00661661 and NCT00413699.

Value-based healthcare (VBHC) strives to improve the healthcare system by focusing on value of care, that is, patient relevant outcomes relative to the costs for achieving these outcomes. Within VBHC, patient participation is crucial to identify patient relevant outcomes and value improvement potential. However, patient participation in VBHC initiatives remains limited. Therefore, we aimed to improve patient participation within VBHC teams with the ultimate aim to develop a practical guide for patient participation in VBHC.

An action research study.

This study was conducted in seven collaborating Dutch hospitals from March 2023 to November 2024.

Seven VBHC teams were selected to participate in the cyclical action research steps, that is, orientation, planning, implementation, and evaluation, in which patient participation was implemented or improved. These included the following patient groups: prostate cancer, vulnerable elderly, breast cancer, diabetes, maternity care, colorectal cancer and chronic kidney disease.

Both qualitative and quantitative data were collected. Qualitative data included observations and minutes of meetings with the intervention teams. Quantitative data included responses to the Public and Patient Engagement Evaluation Tool (PPEET) by multiple members of the intervention (n=7) and control teams (n=94) at three time points (T1=6 months, T2=12 months, T3=end of study). Qualitative data were thematically analysed and quantitative data were analysed descriptively. Finally, the data were triangulated to create an overview of lessons learnt in improving patient participation.

Patient participation goals varied across teams, leading to diverse actions, such as establishing a diabetes patient panel and distributing questionnaires to patients with colorectal cancer. PPEET results show that 71% of intervention team members reported that patient participation had an impact on the team’s outcomes compared with 44% in control teams (T3). Furthermore, 80% of the intervention team members initially wanted training in patient participation (T1), which dropped to 29% at T3. Overall, 22 lessons in improving patient participation in multidisciplinary project teams were identified and compiled into a practical guide.

The action research process improved the process and impact of patient participation in the intervention teams. Furthermore, the results indicate that the action research process enhanced the team members’ knowledge and skills on patient participation. The practical guide developed in this study can be used to support implementation of patient participation in VBHC.